System and method for implanting a heart implant

• US 9,259,317 B2
• Filed: 09/12/2008
• Issued: 02/16/2016
• Est. Priority Date: 06/13/2008
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Wilson, Jonathan E., Maurer, Christopher W., Piemonte, Thomas C., Kirker-Head, Carl
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US12/209,686
• Publication Number:
  US 20090048668A1
• Time in Patent Office: 2,713 Days
• Field of Search: 623 22- 225, 623/2.27, 606/200
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A method and system according to one embodiment may include a plurality of apparatus configured to percutaneously deliver a heart valve implant. The method and system may include an implant comprising an anchor configured to engage cardiac tissue, a shaft coupled to the anchor, and a valve body coupled to the shaft. The method and system may further include at least partially collapsing the heart valve implant and percutaneously inserting the heart valve implant into a heart. The percutaneously inserted implant may be secured within the heart and may then be expanded.

Claims

1. A heart valve implant comprising:

a spacer comprising a cage and a resiliently flexible balloon disposed over at least a portion of the spacer cage, wherein said resiliently flexible balloon is configured to contact at least a portion of at least one cusp of a mitral valve to at least partially restrict a flow of blood through said mitral valve in a closed position and to allow blood flow through said mitral valve in an open position of the valve;

a shaft having a first end configured to be coupled to said spacer;

an anchor configured to be coupled to a second end of said shaft, said anchor configured to removably secure said implant to engage native cardiac tissue within a ventricle; and

a gimbal pivotally coupling said anchor to a second end of said shaft, said gimbal configured to provide a degree of movement with respect to said anchor when said anchor is secured in said tissue to allow said spacer to self-align with respect to said at least a portion of said at least one cusp of said mitral valve to at least partially restrict a flow of blood through said mitral valve in said closed position.

2. The implant of claim 1, wherein said shaft is configured to bend to provide said degree of movement.

3. The implant of claim 1, wherein said spacer is configured to at least partially expand from a collapsed configuration wherein said spacer is configured to be received in and advanced along a lumen of a delivery catheter to an expanded configuration wherein said spacer is configured to contact at least a portion of at least one cusp of a mitral valve to at least partially restrict a flow of blood through said mitral valve in a closed position.

4. The implant of claim 3, wherein said spacer is generally cylindrical.

5. The implant of claim 4, wherein said spacer further comprises a generally conically shaped region proximate a first and a second end region of said spacer.

6. The implant of claim 1, wherein said cage is resiliently flexible and coupled to said first end of said shaft.

7. The implant of claim 6, wherein said resiliently flexible cage further comprises a frame or ribbed structure configured to provide additional support to said resiliently flexible balloon.

8. The implant of claim 7, wherein said resiliently flexible cage comprises a plurality of support ribs extending generally along a longitudinal axis of said implant.

9. The implant of claim 8, wherein said plurality of ribs are configured to resiliently bend radially inwardly and outwardly.

10. The implant of claim 9, wherein said resiliently flexible cage comprises a shape memory material.

11. The implant of claim 1, wherein said anchor comprises a base and a plurality of tines extending generally outwardly from said base, said plurality of tines configured to removably engage native cardiac tissue to removably secure said implant within said heart.

12. The implant of claim 11, wherein said plurality of tines extend generally radially outwardly from said base towards said spacer.

13. The implant of claim 12, wherein said anchor comprises a generally inverted umbrella configuration.

14. The implant of claim 1, wherein said implant further comprises at least one releasable coupler disposed at a proximal end of the shaft configured to releasably engage a delivery device configured to position said implant within said heart.

15. The implant of claim 1, wherein said spacer is configured to contact and seal against said portion of said at least one cusp of said mitral valve to reduce regurgitation through said mitral valve.

16. A heart valve implant comprising:

a spacer comprising a cage and a resiliently flexible balloon disposed over at least a portion of the cage configured to contact at least a portion of at least one cusp of a mitral valve to at least partially restrict a flow of blood through said mitral valve in a closed position and to allow the flow of blood through said mitral valve in an open position of the valve;

a shaft having a first end configured to be coupled to said spacer; and

an anchor configured to removably secure said implant to native ventricular cardiac tissue, wherein said anchor comprises a base and a plurality of tines extending generally outwardly from said base and generally towards said spacer, said plurality of tines configured to removably engage native ventricular cardiac tissue to removably secure said implant within said heart;

wherein said spacer is operatively coupled to said anchor to provide a degree of movement with respect to the anchor when said anchor is secured in said tissue to allow the spacer to self-align with respect to said at least a portion of said at least one cusp of said mitral valve to at least partially restrict a flow of blood through said mitral valve in said closed position.

17. The implant of claim 16, wherein said spacer is configured to contact and seal against said portion of said at least one cusp of said mitral valve to reduce regurgitation through said mitral valve.

18. A heart valve implant comprising:

a spacer comprising a cage and a resiliently flexible balloon disposed over at least a portion of the spacer cage configured to contact at least a portion of at least one cusp of a mitral valve to at least partially restrict a flow of blood through said mitral valve in a closed position and to allow blood flow through said mitral valve in an open position of the valve;

a shaft having a first end configured to be coupled to said spacer; and

an anchor configured to be coupled to a second end of said shaft, said anchor comprising a base and a plurality of tines extending generally outwardly and away from said base and generally towards said spacer, said plurality of tines configured to removably secure said implant to native cardiac tissue within a ventricle of a heart.

19. The implant of claim 18, wherein said spacer is operatively coupled to said anchor to provide a degree of movement with respect to the anchor to allow the spacer to self-align with respect to said at least a portion of said at least one cusp of said mitral valve to at least partially restrict a flow of blood through said mitral valve in said closed position.

20. The implant of claim 19, wherein said second end of said shaft is pivotally coupled to said anchor to provide said degree of movement.

21. The implant of claim 20, further comprising a gimbal pivotally coupling said second end of said shaft to said anchor.

22. The implant of claim 19, wherein said shaft is configured to bend to provide said degree of movement.

23. The implant of claim 18, wherein said spacer is configured to contact and seal against said portion of said at least one cusp of said mitral valve to reduce regurgitation through said mitral valve.